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ICP Threshold After Decompressive Craniectomy

Sponsor
Tang-Du Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06083792
Collaborator
(none)
240
Enrollment
26.7
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Severe traumatic brain injury (sTBI) is a critical disease of public health importance. Increased intracranial play a significant role in the secondary injury of TBI. Reducing the ICP is helpful in reducing the mortality of sTBI. The threshold of ICP for sTBI has been suggested. The threshold of ICP for sTBI after decompressive craniectomy is not clear.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    240 sTBI patients who meet the inclusion criteria will be enrolled in the present study.

    All sTBI patients will be screened. If meeting the including criteria, the investigators will contact the family, explain the study, and send a consent form for review.

    After obtaining written consent from the family, the ICP and blood pressure will be monitored continuously until retraction of ICP sensor. A mean ICP of each patient will be calculated. The neurological outcome will be assessed at 180 days after injury. A threshold for ICP after decompressive craniectomy will be derived by analyzing the association between mean ICP and neurological outcome.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    240 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    ICP Threshold of Severe Traunatic Brain Injury After Decompressive Craniectomy
    Anticipated Study Start Date :
    Oct 8, 2023
    Anticipated Primary Completion Date :
    Jul 30, 2025
    Anticipated Study Completion Date :
    Dec 30, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Modified Glasgow Outcome score [180 days after injury]

      neurological outcome

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • history of traumatic brain injury age: 18-80 years admission GCS scoreā‰¤8 admitting to hospital with 24 hours after injury received decompressive craniectomy received invasive ICP monitoring
    Exclusion Criteria:
    • refuse follow-up received operation before admitting to hospital received cardio-pulmonary resuscitation after injury disturbance of consciousness caused by non-traumatic reasons prior history of traumatic brain injury or stroke expected lifetime less than 180 days admitting to other ongoing study systemic disease: uremia, liver cirrhosis, malignant tumor, mental disease, drug or alcohol dependence

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Tang-Du Hospital

    Investigators

    • Principal Investigator: Yan Qu, Tang-Du Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tang-Du Hospital
    ClinicalTrials.gov Identifier:
    NCT06083792
    Other Study ID Numbers:
    • K202307-17
    First Posted:
    Oct 16, 2023
    Last Update Posted:
    Oct 16, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Brain Injuries
    Brain Injuries, Traumatic

    Study Results

    No Results Posted as of Oct 16, 2023